Medtronic has released data reinforcing the durability and safety of the IN.PACT Admiral drug-coated balloon (DCB) in patients with peripheral artery disease (PAD). The two-year, real-world results from the full clinical cohort of the IN.PACT Global Study and four-year results from the pivotal IN.PACT SFA Study were presented in two late-breaking clinical trial presentations at the Vascular Interventional Advances 2017 conference (VIVA; 11-14 September, Las Vegas, USA).
IN.PACT Global Study
Thomas Zeller (Universitaets-Herzzentrum, Freiburg-Bad Krozingen, Germany) presented the new, two-year results from the full clinical cohort of the IN.PACT Admiral DCB Global Study. The results are the first two-year, real-world, fully adjudicated DCB data to be presented in a scientific congress, which showed consistent performance in both safety and efficacy for IN.PACT Admiral DCB.
The data were calculated using Kaplan-Meier survival estimates and revealed a freedom from clinically-driven target lesion revascularisation (CD-TLR) rate of 83.3% in a real-world patient cohort with a mean lesion length of 12.09±9.54cm, 18% in-stent restenosis lesions, 35.5% occluded lesions and 39.9% diabetes subjects. Additional safety and effectiveness outcomes also included low rates of thrombosis (4.5%), occurrences of major target limb amputation (0.7%), and CD-TLR (16.9%) within two years.
“At two years, the IN.PACT Admiral DCB continues to confirm positive outcomes from the IN.PACT randomised trials, demonstrating efficacy, safety, and durability, despite the complexity of these lesions,” said Zeller. “These results also highlight the clinical utility of the IN.PACT Admiral DCB as a primary therapy in treating patients with some of the most challenging PAD cases.”
The IN.PACT Global Study is the largest and most rigorous real-world evaluation of any peripheral artery intervention ever undertaken. It has enrolled over 1,500 patients across 24 countries, including the 1,406 patients in the full clinical cohort presented at VIVA, to characterise the performance of the IN.PACT Admiral DCB in treating real-world patients with challenging and complex lesions. The study included adjudication of events by an independent clinical events committee.
IN.PACT SFA Study
Peter Schneider (Honolulu, USA) presented the first, four-year data outcomes for a DCB, further demonstrating the safety and efficacy of IN.PACT Admiral DCB in patients with PAD. Of the patients who received a repeat procedure within four years, those in the IN.PACT Admiral DCB group showed that time to reintervention was approximately double that of those in the percutaneous transluminal angioplasty (PTA) group (average 739.2±384 days for IN.PACT Admiral DCB versus 302.9±213 days for PTA [p<0.001]).
Using Kaplan-Meier survival rate estimates, IN.PACT Admiral DCB continued to outperform in freedom from CD-TLR compared to PTA with a 76.8% compared to 70.4% in PTA (p=0.0399). The data also showed the long-term safety benefits of the IN.PACT Admiral DCB, with no major target limb amputations, a low rate of thrombosis, and no major adverse events from years three to four in the IN.PACT Admiral DCB group.
“With the IN.PACT Admiral DCB, pre-clinical studies have demonstrated that the drug remains in the tissue for approximately six months. Therefore, at four years, we would expect to see some catch up effect and at least some late progression of atherosclerosis,” said Schneider. “However, in the four-year data from IN.PACT SFA, we are still seeing sustained durability and clinical benefit. For patients suffering with this chronic condition, these findings are not only encouraging from a therapeutic perspective, but are also suggestive of improved quality of life, with patients requiring fewer reinterventions over time compared to PTA and leaving future treatment options open.”
The IN.PACT SFA trial enrolled 331 patients at 57 sites across Europe and the USA who were randomised to treatment with either the IN.PACT Admiral DCB or PTA. The four-year data includes a total of 284 patients (184 DCB and 103 PTA).
“PAD is a chronic condition associated with disease progression and often requires repeat interventions to manage the disease,” said Mark Pacyna, vice president and general manager of the Peripheral business in the Medtronic Cardiac & Vascular Group. “In partnership with the clinical community, our objective has been to develop a safe, effective, and sustainable treatment option for these patients. The data presented reflect this goal and our commitment to timely and transparent data releases. We are excited to see consistency in real-world patients and fewer interventions out to four years, which was statistically significant.”